Safety
Instructions for use • KARL STORZ OR1 FUSION
®
, Rel. 1.4.2 • JEB924_EN_V1.0_02-2021_IFU_CE-MDR
8
Prepare to use the direct line between the endoscopic camera and monitor, as the product
can fail as a result of excessively high temperatures.
Inforn the service.
Before each intervention, ensure that personnel are trained in dealing with the direct line
(substitute system).
3.5 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
lead to malfunctions and injuries.
Additional devices connected to electrical medical equipment must comply with the relevant
IEC or ISO standards. Furthermore, all configurations must comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1).
Any person who connects additional devices or components to the product changes the
medical electrical system and is therefore responsible for ensuring that it complies with the
requirements for medical electrical systems.
Only combine the product with devices and components that are approved for joint use by
the manufacturer.
Only use approved accessories.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Only use devices that can be displayed in the monitor as a "playback device."
Perform an equipment test before use.
Comply with national and local regulations.
Only make changes to the product if these changes are approved by .
3.6 Dangers from electrical current
An improper power supply may cause an electric shock and injure patients, users, or third
parties. All electrical installations of the operation room in which the product is connected and
used must meet the applicable IEC standards. Input and output equipment connected to the
product must comply with IEC 60601-1.
Have the device installed and put into service by authorized and trained electricians of or
by companies authorized by .
Use either the power cord supplied by or a power cord which has the same properties and
which bears a national mark of conformity.
The product may only be operated with the line voltage stated on the rating plate.
Position the product appropriately so that the power cord can be unplugged at any time.
The product is only voltage-free when the mains plug has been disconnected.
Ensure potential equalization according to the applicable national rules and regulations.
To ensure reliable protective earth grounding, connect the product to a properly installed
socket that is approved for use in the operation room. Routinely inspect the electrical plug
and cord and do not use if the inspection reveals damage.
Connect the product to a power supply with protective conductor.
If several devices are connected to the product, note the maximum leakage current.
Do not use any additional multiple socket outlets or extension cables.
Do not use freely accessible multiple socket outlets.
Multiple socket outlets must not be placed on the floor.
